Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the u
FDA device recall Z-0112-2014 · posted 2013-10-30 · Terminated
Recall details
- Recalling firm
- Fujinon Inc
- Reason for recall
- A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
- Action taken
- The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an "URGENT-MEDICAL DEVICE CORRECTION (UMDC)" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached "Customers Acknowledgement" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: gwalljasper@fujifilm.com. If you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: gwalljasper@fujifilm.com.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- FDS
- Quantity affected
- 12 Units
- Distribution
- Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
- Date initiated
- 2013-07-31
- Date posted
- 2013-10-30
- Date terminated
- 2014-03-04
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 (K120446) | Fujinon, Inc. | 2012-08-13 |